As part of the 2017 FDA Reauthorization Act (FDARA), the RACE for Children Act amended the Pediatric Research Equity Act (PREA) leading to considerable changes in the regulations governing the development of cancer therapies for children. Set to go into effect in August 2020, this law focuses on the requirement for clinically meaningful evaluation of drugs directed at specific molecular targets relevant in pediatric cancer. Shifting the focus from indications to molecular targets, this law eliminates orphan exemptions for pediatric studies for oncology indications. As such, the RACE for Children Act is positioned to considerably change the regulatory landscape of oncology therapy development.
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan. Key topics include:
- Regulatory – requirements of the RACE for Children Act and how this impacts your regulatory strategy and clinical development plans, including study designs
- Pediatric oncology trial management, operational challenges and considerations for efficient and accelerated execution
David Horton, PhD, Director, Regulatory Affairs, Medpace
David Horton is a subject matter expert in pharmaceutical drug development and nonclinical regulatory strategy with over 16 years of research and drug development experience in academic, government (NIH), pharmaceutical industry, and CRO settings. He has strategic development experience with virtually all therapeutic modalities across multiple therapeutic areas and all stages of drug development. In previous roles, he contributed to the design, execution and oversight of CNS, cardiovascular and in vitro safety pharmacology studies. He’s been responsible for advising on efficacy strategy and translational pharmacology in the development of addiction pharmacotherapies in the neuroscience portfolio. He has also been involved in all aspects of nonclinical drug development, including safety pharmacology as well as general toxicology, genotoxicity, immunotoxicology and development and reproductive toxicology.Message Presenter
Peggy Kaiser, MSN, RN, PPCNP-BC, Lead Advanced Clinical Practitioner, Medpace
Peggy Kaiser has over 30 years of experience in pediatric hematology/oncology nursing and pediatric clinical research. Prior to coming to Medpace, she was a nurse practitioner at Cincinnati Children’s Hospital Medical Center in the Cancer and Blood Disease Institute. She served as senior clinical research manager of the institute’s clinical research core, Children’s Oncology Group Phase 1 Consortium, and as interim director of the Translational Research Clinical Trials office. Her expertise includes executing a complex cooperative group, pharmaceutical, and sponsor-investigator pediatric hematology/oncology clinical trials involving many different types of investigational products including gene and cellular therapies. Peggy holds a Master of Science degree in Nursing and is board-certified as a pediatric nurse practitioner. She is a member of the Association of Pediatric Hematology/Oncology Nurses (APHON) and the Oncology Nursing Society (ONS).Message Presenter
Who Should Attend?
VPs, Directors, Managers and Department Heads working within:
- Clinical Affairs
- Clinical Research
- Clinical Pharmacology
- Clinical Outsourcing
- Project Management
- Regulatory Affairs
- Medical Affairs
What You Will Learn
Participants will learn about:
- An overview of the FDA’s RACE for Children Act and PREA
- Impacts of the RACE for Children Act on oncology therapy development
- Changes in requirements for pediatric oncology trials
- Challenges of executing oncology trials in pediatric populations (design and operational considerations)
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,200 people across 37 countries.